Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

March 6, 2025 updated by: Xiamen LP Pharmaceutical Co., Ltd

A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg for the Prevention of CINV in Cancer Patients Receiving MEC

Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
    • Florida
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center PL DBA Florida Cancer Affiliates
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Edward H. Kaplan MD & Associates
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Hematology/Oncology
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Monongahela, Pennsylvania, United States, 15063
        • Monongahela Valley Hospital/ Regional Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • With histologically or cytologically confirmed malignant disease;

    -. Be scheduled to receive the first course of MEC to be administered on Day 1

  • Using reliable contraceptive measures;
  • negative serum pregnancy test (if potentially child bearing)

Exclusion Criteria:

  • Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
  • Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
  • Have severe renal or hepatic impairment;
  • Have positive serology test results;
  • Have a known contraindication to 5-HT3 receptor antagonists;
  • Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
  • Allergic to palonosetron or any other 5-HT3 antagonist;
  • Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
  • Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
  • Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A (Buccal 0.25 Mg)
Palonosetron HCl Buccal Film 0.25 Mg
Drug: Palonosetron Hydrochloride Buccal Film 0.25 Mg
Dose equal to the iv control
Other Names:
  • Buccal Film Low Dose
Experimental: B (Buccal 0.5 Mg)
Palonosetron HCl Buccal Film 0.5 Mg
Drug: Palonosetron Hydrochloride Buccal Film 0.5 Mg
Dose twice that of iv control
Other Names:
  • Buccal Film High dose
Active Comparator: C (IV Injection 0.25 Mg)
IV palonosetron 0.25 Mg (ALOXI®)
Drug: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
iv control
Other Names:
  • Control Standard Treatment (Aloxi)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete Acute Response
Time Frame: first 24 hours after chemotherapy
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
first 24 hours after chemotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete delayed response
Time Frame: 24-120 hours post chemotherapy
no emetic episode and no rescue medication
24-120 hours post chemotherapy
Complete response
Time Frame: up to 120 hours post chemotherapy
no emetic episode and no rescue medication
up to 120 hours post chemotherapy
No nausea
Time Frame: up to 120 hours post chemotherapy
visual analog scale (0-100 mm, 0=no, 100=severe) < 5 mm
up to 120 hours post chemotherapy
No significant nausea
Time Frame: up to 120 hours post chemotherapy
visual analog scale (0-100 mm, 0=no, 100=severe) < 25 mm
up to 120 hours post chemotherapy
Complete protection
Time Frame: up to 120 hours post chemotherapy
no emesis, no rescue therapy, no significant nausea (questionnaire)
up to 120 hours post chemotherapy
Number of emetic episodes
Time Frame: up to 120 hours post chemotherapy
Number of emetic episodes
up to 120 hours post chemotherapy
Time to rescue medication
Time Frame: up to 120 hours post chemotherapy
Time to rescue medication
up to 120 hours post chemotherapy
Time to treatment failure
Time Frame: up to 120 hours post chemotherapy
time to first emetic episode or administration of rescue therapy, whichever occurred first
up to 120 hours post chemotherapy
Severity of nausea
Time Frame: up to 120 hours post chemotherapy
Rhodes Index of Nausea, Vomiting and Retching (0-4, 0=no nausea, 4=severe nausea)
up to 120 hours post chemotherapy
Subject global satisfaction with therapy
Time Frame: up to 120 hours post chemotherapy
visual analog scale (0-100mm, 0=not at all satisfied, 100=totally satisfied)
up to 120 hours post chemotherapy
Quality of life questionnaire
Time Frame: up to 120 hours post chemotherapy
Functional Living Index-Emesis
up to 120 hours post chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen LP Pharmaceutical Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanjit Nirmalanandhan, Ph.D., Ocala Oncology Center PL DBA Florida Cancer Affiliates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP-CT-PALO-202002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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